BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    OAF002001

    Reg #: 3004378299 · FEI: 3004378299 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    28
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    QUANTA SYSTEM, S.P.A.
    Registration Number
    3004378299
    FEI Number
    3004378299
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    VIA ACQUEDOTTO, 109
    City
    SAMARATE Varese
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K131473

    Owner / Operator

    Firm Name
    QUANTA SYSTEM, S.P.A.
    Operator Number
    9057522
    Address
    via Acquedotto 109, --
    City
    Samarate
    State
    Varese
    Postal Code
    21017
    Country
    IT
    Correspondent
    Dario Bandiera

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX

    Proprietary Names

    OAF002001 OAF005511 OAF006011 OAF003611 OAF002701 OAF003601 OAF006001 OAF002711 OAF008001 OAF002011 OAF009911 OAF005501 OAF009901 OAF008011 OAF703611 OAF402011 OAF702701 OAF402711 OAF702791 OAF703601 OAF702711 OAF703691 OAF302711 OAF302721 OAF102791 OAF103691 OAF103611 OAF102711

    Establishment Types

    Manufacture Medical Device